9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PHIPIOLOGICAL SYNCHRONIZER PART#205
FDA 510(k)
FDA Class 2
·Radiology
VITRECTOMY CUTTER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Ophthalmic
ORTHO H FILM
FDA 510(k)
FDA Class 1
·Radiology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 21, 2007
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 10, 2012
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018